Quality Assurance Post Market Specialist
Summary
Review medical-device complaints and adverse events to ensure safety and regulatory compliance, collaborating with cross-functional teams on investigations and reporting.
As the Quality Assurance Post Market Specialist, you will support activities that help ensure the safety, quality, and effectiveness of Stryker products. You will partner with cross-functional teams to evaluate product complaints, support regulatory reporting requirements, contribute to product field actions, and help maintain compliance with global post-market surveillance regulations. Your work will play an important role in supporting patient safety and product performance.
What You Will Do
- Support post-market surveillance activities to ensure compliance with U.S. and international regulatory requirements.
- Review product complaints and adverse event reports to assess reportability and determine whether device use contributed to patient harm.
- Interface with customers to collect patient information and additional details related to adverse event complaints.
- Collect, analyze, and report post-market adverse event data to regulatory agencies and cross-functional stakeholders.
- Support Product Field Action (PFA) and Medical Risk Assessment (MRA) activities.
- Provide quality and regulatory input for nonconformance investigations, CAPA activities, complaint investigations, and audit responses.
- Contribute to the development and maintenance of product hazard analyses and reportability guidance documents.
- Collaborate with Quality, Engineering, Clinical, and Marketing teams to support regulatory decision-making.
- Assist in preparing technical documentation and regulatory submissions.
- Maintain awareness of evolving global post-market surveillance regulations and industry requirements.
What You need
- Bachelor's degree
- 0-2 years of post-market surveillance, quality, regulatory affairs, clinical, or related experience within a regulated industry.
- Strong verbal and written communication skills.
- Strong analytical, organizational, and problem-solving abilities.
- Ability to compose, review, and edit technical documentation.
- Experience collaborating with cross-functional teams.
- Proficiency with Microsoft Office applications, including Word and Excel.
Preferred
- 1 year of post-market surveillance, quality, regulatory affairs, clinical, or related experience within a regulated industry.
- Experience within the medical device industry.
- Prior exposure to medical device product development.
- Clinical or nursing experience.
- Critical care monitoring experience.
- ECG rhythm interpretation skills.
- Familiarity with complaint handling, adverse event reporting, CAPA, risk management, and field action activities.
United States of America Pay Ranges:
- US15: $83,400 - $139,000 USD Annual
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